Industry Outlook

The global aortic valve replacement devices market size was estimated at USD 5.81 billion in 2017. It is anticipated to post a CAGR of 11.1% over the forecast period. Growing prevalence of valvular diseases, such as aortic stenosis & aortic regurgitation, and increasing preference for minimally invasive surgeries are among the key trends stoking market growth. Initiatives undertaken by various government organizations for creating awareness about valve replacement surgeries are also expected to boost the growth of the market.

Rising geriatric population is playing a vital role in the development of the market. In the U.S., elderly population is projected to double by 2050 to 83.7 million from 43.1 million in 2012. According to estimates by Edwards Lifesciences Corporation, approximately 2.5 million people over 75 years in the U.S. suffer from aortic stenosis, which represents nearly 12.4% of population suffering from aortic stenosis. Thus, widening base of geriatric population coupled with high reimbursement rates is likely to significantly increase the demand for replacement surgeries in the U.S.

There are no medications available for reversing the effects of aortic stenosis. Aortic Valve Replacement (AVR) is the recommended treatment for aortic stenosis. Surgical and Transcatheter Aortic Valve Replacement (TAVR) are surgeries preferred for prolonging and improving the quality of life of individuals suffering from valvular diseases. These treatment alternatives are leading to increase in awareness and improved patient outcomes. Thus, advantages of these replacement surgeries are propelling the market.

Technological advancements in replacement surgeries are also positively impacting the market. TAVR is a minimally invasive approach and is less invasive than conventional AVR. Comorbidities & associated mortality are significantly lower for high-risk symptomatic patients. Use of sutureless valves in minimally invasive surgeries results in positive outcomes in terms of patient recovery and postoperative adverse effects.

Rising initiatives for creating awareness about replacement surgeries are also stimulating the growth of the market. The Valve for Life Initiative was launched by European Association of Percutaneous Cardiovascular Interventions. This initiative was aimed at improving access to TAVR in Europe, raise awareness about valvular diseases, increase knowledge of healthcare practitioners, reduce obstacles to therapy implementation, and improve patient outcome.

Surgery Insights

In 2017, the minimally invasive surgery segment accounted for the largest revenue share of 58.2%. This segment is poised to maintain its dominance throughout the forecast period due to surging demand for TAVR and introduction of new products, such as Edwards Intuity Valve System, Enable Valve System, and Perceval Valve System. According to a study by Barnabas Heart Hospital and Rutgers New Jersey Medical School, the number of TAVR procedures was estimated to be approximately 32,000 in 2012 and is anticipated to increase to 1,62,000 by 2020.

TAVR procedures are mostly preferred, owing to lower tissue injury involved and faster patient recovery. According to New England Journal of Medicine, the number of TAVR procedures has increased substantially since its introduction in 2007, as surgical replacement proved to be unsuitable for geriatric patients. In Germany, the number of TAVR procedures has significantly increased from144 in 2007 to 9,147 in 2013 per annum.

Various clinical studies are being conducted by market players to analyze safety and effectiveness of TAVR. According to Annals of Cardiothoracic Surgery, minimally invasive surgeries are safer alternatives for heart valve replacement, demonstrating enhanced postoperative outcomes such as reduced morbidity & mortality, faster recovery, and shorter duration of hospital stay. Owing to the abovementioned factors, the minimally invasive surgery segment is expected to exhibit the fastest CAGR of 13.0% during the forecast period.

Product Insights

In 2017, the transcatheter aortic valve segment dominated the market, with a revenue share of 53.6%. Growing preference for minimally invasive surgeries and increasing research initiatives for developing transcatheter valves are some of the key factors contributing to the growth of the segment. In addition, extensive clinical studies to expand application of transcatheter valves are working in favor of the overall aortic valve replacement devices market.

Increasing preference for TAVR is stirring up the demand for transcatheter aortic valves. Some clinical studies have concluded that TAVR procedures result in less postoperative complications. Furthermore, examination of PARTNER 2A trial and SAPIEN-3 intermediate risk registry concluded that TAVR is more cost-effective than surgical procedures.

The sutureless valves segment is projected to register the highest CAGR of close to 16.0% over the forecast period. This product type has advantages of both surgical tissue valves and minimally invasive transcatheter valves. Advantages include faster patient recovery and fewer postoperative adverse effects. Rising awareness regarding the benefits is supplementing the growth of the segment.

End-user Insights

In 2017, the hospitals segment led the market in terms of revenue, representing a share of 45.5%. A large number of patients catered by hospitals is the primary factor supporting the dominance of the segment. Open surgeries are generally performed in hospitals owing to complexity of procedure and longer recovery time required. Several emerging countries depend on hospitals for primary healthcare, owing to which this segment is likely to maintain its dominance throughout the forecast period.

The others segment includes community and primary healthcare centers. Replacement surgeries can be conducted in these healthcare facilities. These centers are specifically designed for low income and uninsured or underinsured patients. The number of such patients is significantly high in developing regions. Thus, this segment also presents a high growth potential.

Ambulatory centers are poised to emerge as the fastest growing segment, with a CAGR of 12.2% during the forecast period. The number of ambulatory surgery centers is increasing in developed regions. TAVR is emerging as an alternative for conventional surgeries. It is a minimally invasive surgery that can be performed in ambulatory centers, owing to lower complexity of the surgery and less time required for the procedure as well as recovery. All these factors are estimated to benefit the growth of the segment.

Regional Insights

In 2017, North America was the leading revenue contributor, commanding approximately 42.0% of the overall market value. Increasing prevalence of valvular disorders, rising geriatric population, and growing awareness regarding benefits of TAVR over other surgical procedures are some of the key factors stimulating the growth of the regional market. Moreover, favorable government initiatives and reimbursement policies are anticipated to help the market in the region gain tremendous momentum.

The U.S. is at the forefront of the North America market. Nearly 1.5 million people suffer from aortic stenosis in the U.S. According to the data published by Texas Heart Institute, approximately 106, 000 replacement surgeries are performed every year in the country. In addition, local presence of key players and increasing number of clinical studies undertaken by them in the region are augmenting the market. Initiatives undertaken by private institutions are also expected to bolster the growth of the market. For instance, Edwards Lifesciences Foundation is sponsoring American Heart Association’s Valvular Disease Education Center and Ambassador Program in the U.S.

Asia Pacific is projected to be the fastest growing market owing to developing economies, such as China and India. These countries have a high growth potential due to aging population and growing prevalence of heart diseases. Moreover, presence of a large target population, developing healthcare infrastructure and services, increasing disposable income, and rising government funding are some of the factors likely to foster the growth of the regional market during the forecast period.

Aortic Valve Replacement Devices Market Share Insights

Some of the key players in this market are Boston Scientific Corporation, Medtronic, St. Jude Medical, LivoNova, Edwards Lifesciences Corporation, and CryoLife. These companies are developing various strategies such as mergers & acquisitions, extensive clinical studies to extend scope of approved devices, and new product launches to increase their market share.

If you need specific information, which is not currently within the scope of the report, we will provide it to you as a part of customization

Segments Covered in the Report

This report forecasts revenue growth at global, regional, & country levels and provides an analysis of industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research, Inc. has segmented the global aortic valve replacement devices market report based on surgery, product, end user, and region: